Cleared Traditional

K140198 - IMDX HSV-1/2 FOR ABBOTT M2000

K140198 is an FDA 510(k) clearance for IMDX HSV-1/2 FOR ABBOTT M2000, manufactured by Intelligent Medical Devices, Inc.. The device is a Class 2 Microbiology device with product code OQO cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K140198 · Intelligent Medical Devices, Inc. · Microbiology device
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May 2014
Decision
106d
Days
Class 2
Risk

K140198 is an FDA 510(k) clearance for the IMDX HSV-1/2 FOR ABBOTT M2000. Classified as Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO), Class II - Special Controls.

Submitted by Intelligent Medical Devices, Inc. (Beverly, US). The FDA issued a Cleared decision on May 13, 2014 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intelligent Medical Devices, Inc. devices

FDA 510(k) Submission Details - K140198

510(k) Number K140198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date May 13, 2014
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 102d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OQO Device Classification - Class 2, Special Controls

Product Code OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
Definition A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

All 10
Devices cleared under the same product code (OQO) and FDA review panel - the closest regulatory comparables to K140198.
cobas HSV 1 and 2 Test
K150617 · Roche Molecular Systems, Inc. · Jun 2015
SEEGENE ANYPLEX II HSV-1/2 ASSAY
K142156 · Seegene · Feb 2015
artus HSV-1/2 QS-RGQ MDx Kit
K142738 · Qiagen · Dec 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · Quidel Corporation · Mar 2014
ISOAMP HSV ASSAY
K111951 · Biohelix Corporation · Sep 2011
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
K111527 · Eragen Biosciences, Inc. · Aug 2011